Quality Assurance - Equipment Qualification

Role & responsibilities

1. Responsible for preparation of the Validation Master Plan, Computer System Validation Master Plan.

2. To prepare and review of Design Qualification, FAT, URS, Validation protocols & Reports and Qualification protocols & reports.

3. To execute and supervise the qualification and Validation activities for equipment, PLC and utility services and their continuous performance.

4. Responsible for ensuring the compliance with Validation Master Plan and requalification of utility, equipment, procedures and systems as per the frequency described in Validation Master Plan.

5. To ensure compliance to Preventive Maintenance Planner for the equipment.

6. To review of calibration certificates from SAP

7. To verify instrument calibration status.

8. To review raw data /audit trail / software (as applicable) at a given frequency to ensure regulatory guidance compliance.

9. Responsible for preparation of risk assessment and mitigation plan.